Cranial Electrotherapy Stimulation in Burned Patients - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00723008

Purpose

To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to some or all of those symptoms.

Condition	Intervention
Post Traumatic Stress Disorders Burns	Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)

MedlinePlus related topics: Anxiety Burns Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

Cranial electrotherapy stimulation will reduce PTSD in burned outpatients receiving rehabilitation at the USAISR Burn Center. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Alpha Stim 100 will be used for a time period of 2 weeks on and 2 weeks off.	Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation) device

Detailed Description:

The purpose of this research study is to systematically determine if CES therapy is effective in managing post traumatic stress disorder (PTSD) in the burn patient. Cranial Electrotherapy Stimulation (CES) is the delivery of low-level electrical stimulation across the head, delivered with ear lobe electrode clips or self-adhesive electrode pads. CES in the current form has been used for the past 30 years to successfully treat anxiety, depression, insomnia and pain in a variety of patient populations. This FDA approved medical device is non-invasive and has no reported significant side effects.rn patient undergoing outpatient rehabilitation in our burn center.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

burned patients requiring outpatient physical or occupational therapy in the USAISR Burn Rehabilitation Gym or Center for the Intrepid
Able to read and speak English
Between ages of 18-65 years
Screen positive (score greater than 44) on the PCL-M/C instruments

Exclusion Criteria:

pregnant patients
patients with implantable pacemakers or electronic stimulators
patients scoring below 44 on the PCL-M/C instrument
patients who previously used CES therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723008

Contacts

Contact: Kathryn A. Gaylord, RN, MSN, PhD	210-916-0859	kathryn.gaylord@amedd.army.mil
Contact: Annette R. McClinton, RN, MA	210-916-2834	annette.mcclinton@amedd.army.mil

Locations

United States, Texas
USAISR	Recruiting
Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Kathryn Gaylord, RN, MSN, PhD

United States Army Institute of Surgical Research

More Information

Publications:

Schroeder MJ, Barr RE. Quantitative analysis of the electroencephalogram during cranial electrotherapy stimulation. Clin Neurophysiol. 2001 Nov;112(11):2075-83.

Responsible Party:	USAISR ( Kathryn Gaylord, COL, AN )
Study ID Numbers:	H-07-024
Study First Received:	December 25, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00723008
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

anxiety
insomnia
pain
Alpha Stim
Cranial electrotherapy stimulation

Study placed in the following topic categories:

Burns
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic

Stress
Pain
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on January 16, 2009